MAUDE Adverse Event Report: COVIDIEN LP LIGASURE ADVANCE PISTOL GRIP; LIGASURE VESSEL SEALING SYSTEM

Model Number LF5544

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2014

Event Type  Injury  

Event Description

The customer reported that the jaws became splayed during use at the very beginning of the procedure.The case was for a single incision laparoscopic hysterectomy.Nothing fell off the device and there was no patient injury.The staff opened another device of the same type and completed the case.Upon receipt for investigation the knife blade was protruding from the jaws of the device.

Manufacturer Narrative

(b)(4).One used lf5544 was received for evaluation and visual inspection found the knife is trapped and protruding from the jaws causing the jaws to splay.The customer reported that the jaws became splayed during use at the very beginning of the procedure.The reported condition was confirmed.The knife is trapped and protruding from the jaws causing the jaws to splay.Knife trap happens when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.Tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have also reduced the difficulty activating the knife.The investigation identified the root cause of the reported event to be knife trap due to user error.The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.Manufacturing non-conformances were reviewed and no entries pertinent to the customer's report were noted.

• Brand Name: LIGASURE ADVANCE PISTOL GRIP
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO ; 2034925267
• MDR Report Key: 4330489
• MDR Text Key: 5213069
• Report Number: 1717344-2014-01036
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 42610029X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1